Long-Term Data of Efficacy, Safety, and Tolerability in a Real-Life Setting of THC/CBD Oromucosal Spray-Treated Multiple Sclerosis Patients

J Clin Pharmacol. 2016 Jul;56(7):845-51. doi: 10.1002/jcph.670. Epub 2015 Dec 30.


Delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray was approved as add-on therapy for spasticity in patients with multiple sclerosis (MS). We show our 40-week postmarketing experience regarding efficacy and safety of THC/CBD spray in an Italian cohort of 102 MS patients. Patients were evaluated using the Expanded Disability Status Scale (EDSS) score, the Numerical Rating Scale (NRS) for spasticity, the Ambulation Index (AI), and Timed 25-Foot Walk (T25-FW) at the beginning of treatment and then every 3 months. After 4 weeks, if a clinically significant improvement in spasticity (at least 20% of baseline NRS score) was not seen, administration of the drug was stopped. In our cohort, patients received an average of 6.5 ± 1.6 sprays each day. The mean reduction to the NRS spasticity score was 2.5 ± 1.2 points (P < .0001). Thirty-seven patients (36.2%) discontinued the treatment. The incidence of adverse events (AEs) was 40.2%. Fifty-eight patients (56.9%) were also assessed using the NRS for pain, and 46 patients (45.1%) with bladder dysfunction were assessed for the IPSS (International Prostatic Symptoms Score) score, showing a significant improvement in these scales (P = .011 and P = .001, respectively). In conclusion, treatment with THC/CBD spray appears to be a valid answer to some of the unmet needs in MS patients, such as spasticity and other refractory-to-treatment symptoms.

Keywords: THC/CBD; bladder dysfunction; multiple sclerosis; pain; spasticity.

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Cannabidiol / administration & dosage*
  • Cohort Studies
  • Dronabinol / administration & dosage*
  • Female
  • Follow-Up Studies
  • Humans
  • Italy / epidemiology
  • Male
  • Middle Aged
  • Mouth Mucosa / drug effects*
  • Mouth Mucosa / metabolism
  • Multiple Sclerosis / diagnosis*
  • Multiple Sclerosis / drug therapy*
  • Multiple Sclerosis / epidemiology
  • Muscle Spasticity / diagnosis
  • Muscle Spasticity / drug therapy
  • Muscle Spasticity / epidemiology
  • Oral Sprays*
  • Time Factors
  • Treatment Outcome
  • Young Adult


  • Oral Sprays
  • Cannabidiol
  • Dronabinol